BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2840984 · Received November 20, 2012

    Report

    Report Number
    2050012-2012-01865
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 3, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GENERATING A FALSE LOW CALC (CALCIUM) RESULT FOR A PATIENT FROM A UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER ALSO NOTED THAT THE ORIGINAL CO2 RESULT FOR THE PATIENT WAS 53 MMOL/L BUT THE INSTRUMENT PRINTOUT PROVIDED SHOWS THAT THE CO2 RESULT WAS SUPPRESSED. THE OTHER ION SELECTIVE ELECTRODE (ISE) RESULTS FOR THE SAME PATIENT WERE ALSO SUPPRESSED AND NO RESULTS WERE GENERATED AS INDICATED BY THE INSTRUMENT PRINTOUT. THE INSTRUMENT PRINTOUT ALSO INDICATED THAT THE ORIGINAL CALC RESULT WAS 5.9 MG/DL WITH AN AUTOMATIC CRITICAL RERUN OF 5.5 MG/DL. THE CUSTOMER STATED THAT THE SAMPLE WAS RERUN AGAIN AND A CALC RESULT OF 9.3 MG/DL WAS RECOVERED AND REPORTED OUT OF THE LAB. IT IS UNKNOWN OF WHETHER THE SAMPLE WAS RERUN ON THE ORIGINAL OR ALTERNATE INSTRUMENT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THE EVENT. IT WAS ALSO NOTED THAT THE QUALITY CONTROL (QC) PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES AND AFTER THE EVENT, THE INSTRUMENT FAILED TO CALIBRATE AND GAVE AN "OBSTRUCTION DETECTION ERROR". BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED THAT THE ISE REFERENCE REAGENT STRAW WAS NOT SEATED ALL THE WAY INTO THE BOTTLE. THE FSE NOTED THAT THE STRAW WAS ONLY HALF WAY DOWN INTO THE REAGENT BOTTLE INSTEAD OF ALL THE WAY DOWN TO THE BOTTOM. THE CUSTOMER HAD REPLACED THE REAGENT ON (B)(6) 2012, AND THE FSE BELIEVED THAT THE STRAW WAS LIKELY INCORRECTLY PLACED AT THE TIME, THEREBY DRAWING ONLY AIR INSTEAD OF REAGENT. FAILURE MODE WAS NOT IDENTIFIED BUT THE FSE BELIEVES THE EVENT WAS CAUSED BY IMPROPER PLACEMENT OF THE REAGENT STRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR